Study of Tezepelumab Compared to Placebo in Adults with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

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What is this study about?

This clinical trial investigates the use of tezepelumab in adults with Chronic Obstructive Pulmonary Disease (COPD). COPD is a long-term lung condition that causes breathing difficulties and can lead to frequent chest infections. The study aims to determine if tezepelumab can reduce the frequency of COPD flare-ups compared to placebo in people with moderate to very severe forms of the disease.

The study medication tezepelumab is given as a subcutaneous injection using a pre-filled syringe. Some participants will receive tezepelumab, while others will receive a placebo. Neither the participants nor their doctors will know which treatment is being given during the study.

The treatment period will last for 76 weeks, during which participants will receive regular injections of either tezepelumab or placebo. Throughout the study, doctors will monitor participants’ breathing ability, symptoms, and how often they experience COPD flare-ups. The study will also track any changes in participants’ quality of life and their ability to perform daily activities.

1 Initial treatment phase

You will receive either tezepelumab or a placebo through subcutaneous injection (an injection under the skin).

The medication used is Tezspire 210 mg solution in a pre-filled syringe.

Your current inhaled therapy for Chronic Obstructive Pulmonary Disease (COPD) will continue during the study.

2 Treatment monitoring – First 52 weeks

Your lung function will be measured regularly using a test called FEV1 (amount of air you can forcefully exhale).

You will complete questionnaires about your symptoms and quality of life.

The medical team will monitor any COPD exacerbations (periods when your symptoms get worse).

Your blood will be tested to measure medication levels and check for antibodies.

3 Extended observation period

The study continues for an additional 24 weeks (total of 76 weeks).

During this time, the medical team will continue to monitor your COPD exacerbations.

The focus will be on tracking both moderate and severe episodes of symptom worsening.

Blood samples will continue to be collected to measure drug levels and antibodies.

4 Final evaluation

Your lung function will be measured one final time.

The medical team will review your complete health status.

All questionnaires about your symptoms and quality of life will be completed for the last time.

A final blood sample will be taken to check medication levels and antibodies.

Who Can Join the Study?

Age between 40 and 80 years old at the time of signing consent
Diagnosed with COPD (Chronic Obstructive Pulmonary Disease) for at least 12 months before first visit
Have specific lung function test results showing:
– Reduced ratio of exhaled air volume (FEV1/FVC less than 0.70)
– Lung capacity between 20% and 70% of normal predicted value
Using either:
– Triple therapy (three different inhaled medications), or
– Dual therapy (two different inhaled medications) for at least 3 consecutive months before first visit
History of either:
– At least 2 moderate COPD flare-ups, or
– At least 1 severe COPD flare-up in the past 12 months
– At least one flare-up must have been treated with steroids
Blood test showing specific white blood cell count (eosinophils at least 150 cells per microliter)
CAT score (COPD Assessment Test measuring symptoms) of 15 or higher at first visit
Must be either:
– Current smoker, or
– Former smoker who quit at least 6 months ago
– Must have smoked equivalent to 10 pack-years (for example: 1 pack per day for 10 years)

Who Cannot Join the Study?

History of asthma or any other chronic respiratory condition besides COPD
Current active lung infection or tuberculosis
Major surgery within the past 3 months
Unstable heart conditions (like recent heart attack or uncontrolled high blood pressure)
Current cancer treatment or active cancer
Participation in another clinical trial within the past 30 days
Allergic reactions to similar medications in the past
Current use of other biological therapies (special types of medications that affect the immune system)
Severe liver or kidney disease
Autoimmune disorders (conditions where the body’s immune system attacks its own tissues)
History of substance abuse within the past 6 months
Pregnant women or women planning to become pregnant during the study
Breastfeeding mothers
Unable to perform breathing tests or use inhalers properly
Any condition that the study doctor believes would make participation unsafe

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Azienda Ospedaliero Universitaria Di Sassari	Sassari	Italy
Hospital Universitario De Navarra	Pamplona	Spain
Plicni alergo s.r.o.	Ostrava	Czechia
Lungenfacharztzentrum an den Quellen	Wiesbaden	Germany
Meditrez s.r.o.	Kosice	Slovakia
Zbigniew Zegota Specjalistyczny Osrodek Leczniczo – Badawczy	Ostróda	Poland
Pneumologicum	Hanover	Germany
Lungenfachklinik	Immenhausen	Germany
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy

Other Sites

Site Name	City	Country
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Alergologia Plus Sp. z o.o.	Poznan	Poland
Fakultna Nemocnica Trnava	Trnava	Slovakia
Promed P.Lach R.Glowacki Sp. j.	Cracow	Poland
Clinical Best Solutions Sp. z o.o. S.K.	Lublin	Poland
Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j.	Bydgoszcz	Poland
Hospital Universitario Virgen De Las Nieves	Granada	Spain
Centrum Medycyny Oddechowej Mroz Sp. j.	Bialystok	Poland
Zentrum Fuer Ambulante Pneumologische Forschung Marburg GbR	Marburg	Germany
MediTrial s.r.o.	Jindřichův Hradec	Czechia
Plicni Stredisko Teplice s.r.o.	Teplice	Czechia
Romed Klinikum Rosenheim	Rosenheim	Germany
B&R Clinical Sp. z o.o.	Kielce	Poland
Pro Familia Altera Sp. z o.o.	Katowice	Poland
Azienda Unita’ Locale Socio Sanitaria N. 2 Marca Trevigiana	Treviso	Italy
Mcbk s.c. Iwona Czajkowska Anna Podrazka Szczepaniak	Grodzisk Mazowiecki	Poland
Fakultni Nemocnice Plzen	Plzen	Czechia
Velocity Clinical Research Luebeck GmbH	Luebeck	Germany
Virgen del Rocío University Hospital	Sevilla	Spain
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Universita’ Campus Bio-medico Di Roma	Rome	Italy
Hospital Clinic De Barcelona	Barcelona	Spain
Fakultni Nemocnice Brno	Brno	Czechia
Hospital Universitario De Cruces	Barakaldo	Spain
Pratia S.A.	Skorzewo	Poland
Fondazione Salvatore Maugeri Clinica Del Lavoro E Della Riabilitazione	Pavia	Italy
Universita’ Degli Studi Di Ferrara	Ferrara	Italy
Servei De Salut De Les Illes Balears	Palma	Spain
MUDr. I. Cierna Peterova s.r.o.	Brandys Nad Labem	Czechia
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Zapa Jj s.r.o.	Levice	Slovakia
Pegsnhpzslr Vtadbeexn svcthj	Varnsdorf	Czechia
Ihkiowy scpujc	Humenne	Slovakia
Pupyob cltqnog sqglhb	Prague	Czechia
Orstzcky cuxmet pwtxfaxr sjsklj	Prague	Czechia
Srgernh Pfjhjkbvh W Cyafacfmlx	Chrzanow	Poland
Ealfifha Sjk z octv	Karczew	Poland
Cap Msd Czioiy	Plock	Poland
Czlxbnu Iyvffyullnrxq Tedngvu Soy z oxiw	Piaseczno	Poland
Hedixx Hbejmcvq	Herlev	Denmark
Kwpw Givc	Bendorf	Germany
Clmgrhyad sqdelt	Lovosice	Czechia

Trial status

Country	Status	Recruitment Start
Czechia	Recruiting	02.06.2025
Denmark	Recruiting	02.06.2025
Germany	Recruiting	02.06.2025
Italy	Recruiting	02.06.2025
Poland	Recruiting	02.06.2025
Slovakia	Recruiting	02.06.2025
Spain	Recruiting	02.06.2025

Trial locations

Investigated drugs:

Tezepelumab

Tezepelumab is a medication being studied for people with moderate to very severe Chronic Obstructive Pulmonary Disease (COPD). It is designed to reduce the frequency and severity of COPD flare-ups (exacerbations). This medication works by targeting specific proteins in the body that are involved in airway inflammation, which is a key feature of COPD. It is given to patients alongside their regular COPD treatments.

Investigated diseases:

Chronic obstructive pulmonary disease

Chronic Obstructive Pulmonary Disease (COPD) – A progressive respiratory condition that makes breathing difficult due to obstruction of airflow in the lungs. The disease causes the airways to become inflamed and narrowed, while also damaging the tiny air sacs (alveoli) in the lungs. COPD typically develops slowly over years, with symptoms including persistent coughing, increased mucus production, wheezing, and shortness of breath, especially during physical activities. The condition often results in reduced lung function and can affect daily activities. The airways become less elastic over time, making it harder to breathe out properly.

Trial ID:

2024-517458-90-00

Protocol code:

D5241C00006

NCT ID:

NCT06883305

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of Tezepelumab Compared to Placebo in Adults with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?